職位描述
ROLE AND RESPONSIBILITIES
The Safety and Regulatory Engineer(SRE) role combines skills of Safety engineer and Regulatory affairs (pre and post market), and will engage in product development teams to ensure safety and compliance.
1、Engaging with program management team to provide SRE deliverables such as Compliance Plan and regulatory requirements, Technical Files.
與項目組合作撰寫各法規相關文檔。
2、 Work closely with regulatory, engineering, marketing, and other cross team to get all target countries regulatory compliance, including CFDA, 510K, CE etc.
與法規，工程師，市場團隊一起保證產品符合銷售國家的法規，主要地區包括中國，美國和歐洲。
3、 Work closely with engineering team to pass typing test and TUV testing.
與工程師團隊一起保證產品通過型式試驗和TUV測試。
4、 Screening new regulatory requirement, interpret(Impact assessment), implement & compliance check, to ensure the products compliance and on time implement all new regulatory requirements.
篩選并解讀法規要求，保證產品設計符合法規要求。
5、 Support regulatory inspections as required
支持法規檢查。
6、 Other tasks assigned by the leader
其他未盡事宜。
QUALIFICATIONS AND EDUCATION REQUIREMENTS
1、Bachelor degree or above in science and technology majors.
學士學位及以上，科學技術相關專業。
2、At least 5 years Safety and Regulatory experience, medical device industry experience is preferred.
5年以上安全法規工程師經驗，醫療行業優先。
3、Ability to communicate in English and Mandarin, written and spoken, Excellent interpersonal and team work skills.
具有良好的中英文寫作和口頭表達能力，有良好的團隊協作和溝通能力。
4、Quick study ability and clear thinking.
快速學習能力以及思維清晰。
企業介紹
新瑞陽光粒子醫療裝備（無錫）有限公司是總部位于美國加州硅谷的NewRT Medical Systems, Inc.在中國的全資子公司。公司由一批來自全球頂尖放療設備廠商Varian, IBA, 美國著名大學和國家實驗室的高級專家和高級技術管理人員創建，并獲得美元基金的巨額投資和無錫當地政府的大力支持，專注于新一代影像引導放療裝置的開發、生產和銷售，立志打造世界水平的國產化先進放療裝置。
公司誠邀有志于挑戰癌癥，造福患者的精英加盟，共同打造中國創造的頂尖放療裝置，為癌癥患者帶來新的陽光！
